EUCTR2016-000136-17-DE
Active, not recruiting
Phase 1
Prospective, randomized, multicenter clinical trial on the impact of Therapeutic Drug Monitoring (TDM) of piperacillin on organ functions and survival in the treatment of severe sepsis or septic shock - Target
Friedrich Schiller University Jena0 sites276 target enrollmentApril 8, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with a severe sepsis oder a septic shock treatet with piperacillin/tazobactam
- Sponsor
- Friedrich Schiller University Jena
- Enrollment
- 276
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with severe sepsis or septic shock
- •onset of severe sepsis or septic shock not longer than 24 hours prior to randomization
- •Antimicrobial therapy with piperacillin planned or started
- •age \=18 years
- •written informed consent of the patient or legal representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 176
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •pregnant or breast\-feeding women
- •anamnestic known hypersensitivity against beta\-lactam antibiotics or another part of the investigational medicinal product
- •previous treatment with piperacillin (in combination with tazobactam) \> 24 hours before randomization
- •participation in another interventional clinical trial
- •previous participation (TARGET)
- •limits of therapy or cessation
- •impaired liver function (Child\-Pugh C)
- •life expectancy \< 28 day due to accompanying illnesses
- •piperacillin\-measurement impossible within 24 hours after randomization
Outcomes
Primary Outcomes
Not specified
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